MXPA06004677A - Device for removing and/or injecting bone marrow and system comprising said device - Google Patents

Abstract

A device for removing and/or injecting bone marrow (1), comprising a gripping area (2), a needle (10) having at least one lateral opening (15), a protective sleeve (20) which covers at least partially said needle (10) and which is mounted in relation to the needle (10) in such a way that it can move between a position in which the at least one lateral opening (15) is closed and an position in which the at least one lateral opening is open.

Description

DEVICE FOR REMOVING AND / OR INJECTING BONE MEDULA AND SYSTEM THAT COMPRISES THE DEVICE FIELD OF THE INVENTION The present invention relates to a device for removing and / or injecting bone marrow, as well as a removal and / or injection system incorporating that device.

BACKGROUND OF THE INVENTION The removal of bone marrow is currently performed with the aid of a hollow needle that has an axial hole through which the marrow flows. That type of removal requires an internal rod (or mandrel) that is inserted into the needle. The function of this rod is to prevent the total filling of the needle hole, especially by bone chips during the penetration stage of the needle in the bone. During the removal step as such, the rod is removed from the needle and replaced by a syringe. The user then aspirates the marrow by means of that syringe, via the hole in the needle. The aspirated marrow is then transferred to a collection bag and placed in the presence of an anticoagulant. Then, those stages of removal are reiterated, focusing more and more on the needle providing the rod to recruit new bone marrow. This method of removal has many drawbacks. A major disadvantage is that of carrying out a succession of stages in order to arrive at the desired quantity of marrow that can be reached of 1.5 liters. A typical sequence comprises putting the rod in place, penetrating the needle into the bone, retracting the rod, placing the syringe, aspirating the marrow, retracting the syringe and replacing the rod. That sequence can be repeated a plurality of times. The slowness and complexity of the removal are disadvantages related to this type of removal. In effect, this type of removal mobilizes a significant number of people for one to two hours. In general, one or two doctors practice the removal with the help of one or two auxiliaries in charge of placing the bone marrow in the collection bags destined to be stored. Another drawback of this type of removal is related to the successful replacement of the rod with a syringe to aspirate the cord. In this way, the latency times run between the needle bar backhaul and the placement in place of the syringe so that the marrow flows through the hole in contact with ambient air. In this way, this contact with the air of the environment can be a source of microbiological contamination of the marrow removed with the inconveniences that this implies for the result.

SUMMARY OF THE INVENTION The present invention has for its object to provide a device for removing and / or injecting bone marrow, which do not reproduce the aforementioned drawbacks. The present invention also aims to provide a device that can thus be used in an injection mode for example of a bone marrow transplant from a donor to a recipient. Another object of the present invention is to provide a device for removal and / or injection that is used simply, quickly and safely. More specifically, the present invention has as its object a device for removal and / or injection that requires less personnel, reduces the duration of anesthesia of patients and ensures the obtaining of a quality marrow, rich in stem cells or undifferentiated blood Another objective of the invention is to avoid total microbiological contamination of the bone marrow by integrating the removal and / or injection device according to the invention into a sterile removal and / or injection system. The object of the present invention is therefore to provide the device and a system that are simple and can be cheap to manufacture, assemble and use. The subject of the present invention is a bone marrow removal and / or injection device comprising a holding area, a needle having at least one side hole, a protective sleeve which at least partially covers the needle and which is mounted in relation to the needle in such a way that it can be moved to a sealing position in which at least one side opening it is closed and a position in which at least one side opening is open. Advantageously, the protective sleeve of the device is mounted rotatably around the needle. Advantageously, the protective sleeve of the device comprises at least one side opening, at least one lateral hole of the needle in the open position is visibly arranged at least. Advantageously, the needle of the device is fixed in a needle holder, the needle holder comprising receiving means suitable for cooperating with the fixing means in the protective sleeve. Advantageously, the protective sleeve of the device comprises a first part consisting of a covering covering the needle and a second part comprising the fixing means. Advantageously, the fixing means of the device comprise at least one tap mounted rotatably and having a manually operated surface and a projection. Advantageously, the needle holder receiving means comprise at least one slot suitable for receiving at least one projection of the securing means of the protective sleeve. Advantageously, the device comprises a mixing chamber connected to the needle by at least one inlet channel and at least one outlet channel. The present invention also has as its object a bone marrow removal system comprising such a device. Advantageously, the system comprises a mixing chamber connected to the needle of a device by means of at least one inlet channel and at least one outlet channel. Advantageously, an inlet channel is linked to a source of anticoagulant product. Advantageously, an outlet channel is connected to a pith collecting reservoir. Advantageously, the system comprises suction means attached to at least one needle. Advantageously, the suction means comprise a vacuum pump. Advantageously, the suction means are controlled by a control means, such as a pedal operated by the user. Advantageously, the inlet channel projects into the mixing chamber in the direction of the channel to create a venturi effect. Advantageously, the system comprises a timer device for regulating the duration of the bone marrow aspiration phases. The present invention also relates to a bone marrow injection system comprising the removal and / or injection device. Advantageously, the device is attached to a bone marrow reservoir, the reservoir being attached to the dispensing means. Advantageously, the distribution means comprise a pump, such as an electric pusher-syringe or CO2 pump.

Advantageously, the removal and / or injection system is packaged in a sterile manner.

BRIEF DESCRIPTION OF THE DRAWINGS Other characteristics and advantages of the invention will be apparent in the course of the following detailed description of a particular embodiment of the invention, with reference to the attached designs given by way of non-limiting examples, and in which : - figure 1 represents a schematic cross-sectional view of a removal and / or injection device according to an advantageous embodiment of the invention, - figure 2 represents an amplified perspective view, on an amplified scale, of a part of the removal and / or injection device of figure 1, and - figure 3 represents a schematic view of a removal and / or injection system according to an embodiment of the invention.

DETAILED DESCRIPTION OF THE PREFERRED MODALITIES OF THE INVENTION With reference to Figure 1, the device 1 according to the invention comprises at least one holding area 2, a needle 10 and a protective sleeve 20. The device shown can serve both for the removal and injection of bone marrow. The holding area 2 is a surface intended for the user to hold the device during the removal and / or injection of bone marrow. This fastening area can, for example, be made in the form of a sleeve, for example a sleeve similar to that of a handlebar. However, the shape given to that sleeve and its characteristics can be any, the present invention is not limited in any case to that particular embodiment given by way of example. The needle 10 is presented in the form of a hollow body 12 cylindrical terminated by a tip 11 adapted to pierce bone. This needle has an outlet duct 14. According to the invention, the needle comprises at least one side opening 15, advantageously two, near the tip 11, advantageously at the end of a cylindrical body 12. It can be noted that Holes placed on the body of the needle can occur under any form. The needle 10 advantageously cooperates with the needle holder 30. The former can form a single block with the needle, or, as shown in FIG. 2, it can be made separately and be removable and cooperate to fit or fit as it will be. described more broadly later. The protective sleeve 20 advantageously comprises, on the one hand, a first part forming a covering 21 and, on the other hand, a second part comprising fixing means 22. The covering 21 constitutes a tubular coating, advantageously cylindrical covering completely or partially the needle 10. In this way, the needle can be covered over only a part of its length or over only a part of its amplitude provided that the coating cooperates with at least one side hole 15 of the needle. The sleeve 20 is, according to the invention, movably mounted in relation to the needle 10 between a closed position and at least one side hole 15 and an open position of the at least one side hole 15. Advantageously, the cover 21 comprises at least one side opening 25 suitable to be placed in correspondence with a respective lateral hole 15 of the needle, in open position. This lateral opening 25 preferably has a shape corresponding to that of the lateral hole 15 of the needle, which is contemplated differently. In this way, various combinations of shapes can be contemplated which allow the lateral holes 15 of the needle and the lateral openings 25 of the covering to be visually seen in order to define one or a plurality of passages that the bone marrow takes when it is removed. or inject The securing means 22 of the protective sleeve 20 advantageously has an overall shape of fins or taps. According to a preferred embodiment of the invention, the device comprises two fixing means 22 located sensibly vis-a-vis. The fastening means 22 may comprise, on the one hand, a manually operated surface 23 and, on the other hand, a projection 24. The fastening means 22 are advantageously mounted on the fastening bushing 26. lining 21 of the protective sleeve 20 can be made in the form of a monobloc. However, in the example of Figure 2, these two elements are made separately and are removable and cooperate to be fitted or adjusted, as will be described more fully below. Each fixing means 22 can form a lever suitable for rotating about a respective axis 226 between a fixing position and a release position. The manually operated surface 23 of the fixing means projects, advantageously outwardly in order to facilitate the manipulation of the protective sleeve 20 to the user. The projections 24 serve as the anchoring surface of the protective sleeve 20 to the device according to the invention. In the illustrated embodiment, the projections 24 of the fixing means 22 cooperate with the receiving means 34. These receiving means 34 are advantageously presented in the form of grooves arranged radially at the level of the needle holder 30. The needle holder 30 can form a single block assembly with the holding area (or sleeve) 2. The slots 34 may be in a number of four, divided into two pairs 34a, 34b of two slots each. Each pair 34a, 34b comprises two grooves opposite one another in order to allow these grooves to cooperate with two faucets 22, equally opposite each other. In this way, the protective sleeve is movably mounted in relation to the needle 10, the projections 24 will be placed at the level of one or the other pair of grooves 34 according to the chosen position (open or closed). The displacement of the protective sleeve 20 will preferably be for the rotation of the protective sleeve 20 around the needle 10. For this purpose, the user jumps or clears the projections 24 of the taps 22 of the first pair of slots 34a, rotating the protective sleeve 20 around the needle 10, immediately places the projections 24 of the taps 22 into the other pair of slots 34b. Thus, in the first opening position each side hole 15 of the needle is placed in front of a respective side opening 25 of the protective sleeve. This placement contributes to the creation of a passage for the removal and / or injection of bone marrow. The second position of sealing or closing of the lateral hole 15 of the needle is open and is otherwise closed by the lining 21 of the sleeve 20. Thus, in that case, no passage is defined to remove or inject bone marrow preventing then all removal or injection. That second position corresponds to that used to make the needle 10 penetrate the bone. In this way, there is no risk of obstructing the holes 15 of the needle 10 and the insertion into the bone is not effected. It should be noted that the embodiment described above constitutes an advantageous embodiment of the invention, and different variants are contemplated. For example, the displacement of the protective sleeve 20 from the closed position to the open position (and vice versa) can be effected by an axial displacement of the protective sleeve or by a combination that brings into play a rotation and an axial displacement. Likewise, the fastening means 22 of the sleeve 20 can be made differently, and incorporate, for example, locating means to clearly indicate to the user the position of the sleeve in relation to the needle. According to the preferred embodiment of the invention, the device comprises a mixing chamber 13. That mixing chamber 13 attached to the needle conduit 14, at least one inlet channel 31 and at least one outlet channel 32. The conduit 14 of the needle carries the removed bone marrow. At least one entry channel 31 can provide anticoagulant, such as heparin, which serves to prevent the formation of blood clots to the removed bone marrow. At least one exit channel 32 has a mixture of anticoagulant and bone marrow, and can lead to a collection reservoir. These inlet channels 31 and outlet 32 are advantageously placed in one part and on the other side to the mixing chamber 13. In a variant it can be seen that the mixing chamber and at least one inlet channel and at least one channel output are made separate from the removal and / or injection device 1. At least one inlet channel 31 is advantageously projected into the mixing chamber 13 and can therefore be directly placed at the level of at least one channel output 32. This type of placement favors the creation of a venturi effect that results in a better homogenization of the anticoagulant mixture and the bone marrow at the level of at least one exit channel 32. This better homogenization participates in obtaining of a better quality marrow. Figure 2 shows an embodiment of the invention in which the mixing chamber 13 is formed of an inserted element 130 which cooperates with the needle holder 30. In this embodiment, the fixing pins 301 are inserted into the holes 302 , 303, 304 respectively, placed on said inserted element 130, the needle 10 and the needle holder 30 in order to obtain a single block assembly. It can also be envisaged that the pins 301 cooperate with the holes 201 provided in the sleeve 2 to be fixed to that assembly. According to the embodiment, the needle 10 can be provided with a platform 103 that allows to keep the needle on the needle holder 30. That platform is placed in such a way that it allows a free part 101 of the needle 10 to meet with the camera mixed 13. The free part then brings the needle conduit 14 into contact with the mixing chamber 13. In order to facilitate positioning on the needle 10 on the needle holder 30, an indexing means may be provided. That indexing means may, for example, be made up of a hole 105 placed at the level of the formed plate 103 of the needle which cooperates with a protrusion 305 of the needle holder. Thus, when the needle 10 is inserted into the central hole 310 of the needle holder, the platform will be positioned such that the protrusion 305 engages the hole 105. That results in the aligned placement of the holes 303 and 304 that in this way it facilitates the insertion of the fixation pins 301. Similarly, an indexing means can be provided to place in place the inserted element 130 at the level of the platform 103 in order to align the holes 302 and the holes 303 and 304. As described above, the liner 21 of the protective sleeve can be an insert. In this case, the liner 21 is inserted at the level of a hole 265 that passes through the fixing sleeve 26. The protective sleeve 20 is retained thanks to a clamp 203 placed along a complementary form 263 placed at the level of the fixing sleeve. The embodiment described above with reference to figures 1 and 2 is advantageous since the device is easy to assemble and disassemble. The device can then be packaged in a removable and sterile form in a common container. When used, the user will insert the liner 21 of the sleeve 20 into the hole 265 of the bushing 26. He will then place the needle 10 in the needle holder 30, and that assembly will be mounted on the bushing 26, the needle 10 passing over the lining 21. Eventually, the The mixing chamber 13 provided in the inserted element 130 can be mounted on the needle holder 30 by means of the pin 301, before the mounting of the needle holder 30 on the sleeve 26. In the same way, the sleeve 2 can be preassembled with the pins 301. It must be understood that this realization is an example. In particular, the various elements described above can be realized in the form of a single block to limit the number of pieces to be assembled. For example, the mixing chamber 13 can be made in the needle holder 30 and the needle 10 can form a single block with the needle holder 30. The mixing chamber 13 can also be made in the sleeve 2. The sleeve 20 can also be made in the form of a single block. The essential thing is to make the sleeve 20 displaceable in relation to the needle 10 between its closed and open positions. The present invention also relates to a removal system and / or injection system comprising a removal and / or injection device 1 as previously described. Figure 3 presents a preferred embodiment of the removal system. According to that embodiment, an input channel 31 of the device is connected to a source of anticoagulant 40, by means of a pipe 42. An outlet channel 32 is connected to a bone marrow collecting reservoir 50 by means of a pipe 52 The solenoid valves 41 and 51 can be placed respectively at the level of the pipes 42 and 52 in order to control respectively the anticoagulant supply and the removed amount of bone marrow mixed with anticoagulant. The collection reservoir 50 is preferably in relation to the suction means 60. Those suction means can be formed by a single vacuum pump to an electrical connection 70. That vacuum pump creates a depression that entrains the anticoagulant and the pith bone removed at the level of the collection reservoir 50. In a variant, a peristaltic pump or any other appropriate suction means may be used. The system is controlled, advantageously, by means of a single control that controls the opening and closing of the solenoid valves 41 and 51. Those control means 90 can be a pedal operated by the user. An anti-return device 61 can be placed at the level of the pipe 53 connected to the collection reservoir 50 to the suction means 60. This anti-return device 61 is intended to prevent any aspiration of anticoagulant and bone marrow mixture from the collector 50 towards the means of suction 60. A vacuum switch 62 can also be integrated into the removal system. That vacuum switch 62 may also intervene in the opening control of the solenoid valves 41 and 51, at a predetermined thrust vacuum threshold preferably less than 900 millibars. Subsequently, this vacuum switch 62 makes it possible to obtain an effective and strong suction of the opening of the gates, favoring a better reconnection of hematopoietic progenitors and consequently obtaining a richer marrow. On the other hand, the system can integrate a timer 80 that functions as a regulator, especially limiting, of the removal of bone marrow. Other means of regulation are contemplated to determine certain characteristics of the removal. Among those characteristics, duration, intensity, flow rate, frequency, etc. can be noted. The present invention also relates to an injection system useful in the transplantation of bone marrow at the level of bone segments of spongy bones.

In that case, the device 1 is simply connected to a reservoir of bone marrow of the syringe type. That syringe can be manually operated or connected to pump type distribution means, for example an electric push-syringe or other pump, such as a C02 pump, or any other control system, whether electric or not. These means ensure in this way a total control of the speed and the amount of bone marrow to be transplanted. When the device is used in an injection system, the inlet channel 31 of the mixing chamber 13 is preferably closed. For example, that channel 31 can be removed and the resulting orifice closed by any adapted means. The mixing chamber 13 then becomes a simple transit chamber for the marrow. The removal and / or injection device as well as the removal and / or injection system according to the invention are advantageously formed in an equipment. The pieces comprising this equipment are advantageously packaged in sterile form thus avoiding any microbiological contamination. Although the invention has been described with reference to a particular embodiment thereof, it should be understood that it is not limited to that, but on the contrary, that the user can and will provide all useful modifications without departing from the scope of the present invention. which is defined by the appended claims.

Claims (23)

1. NOVELTY OF THE INVENTION Having described the invention as above, property is claimed as contained in the following: CLAIMS 1. A bone marrow removal and / or injection device comprising: - a holding area, - a needle that presents the less a side hole, characterized in that the needle is fixed on a needle holder, and because a protective sleeve at least partially covers the needle, the protective sleeve being movably mounted in relation to the needle between a closed position of at least one side hole and an open position of the at least one side hole and the needle holder comprises receiving means suitable for cooperating with the securing means of the protective sleeve in order to maintain the protective sleeve in the closed position or in the open position. The device according to claim 1, characterized in that the protective sleeve is mounted rotatably around the needle. The device according to claim 1 or 2, characterized in that the protective sleeve comprises at least one side opening, which is placed substantially visually in at least one lateral hole of the needle in the open position. The device according to claim 3, characterized in that the protective sleeve comprises a first part constituting a covering covering the needle and a second part comprising the securing means. The device according to claim 3 or 4, characterized in that the fixing means comprise at least one tap mounted rotatably and having a manually operated surface and a projection. The device according to any of claims 3 to 5, characterized in that the means for receiving the needle holder comprise at least one slot suitable for receiving at least one projection of the fixing means of the protective sleeve. The device according to any of the preceding claims, characterized in that the device comprises a mixing chamber connected to the needle as well as at least one inlet channel and at least one outlet channel. The device according to claim 7, characterized in that the mixing chamber is provided in the needle holder. The device according to claim 7, characterized in that the clamping area comprises a handle, the mixing chamber being provided in the handle. The device according to claim 7, characterized in that it comprises an element inserted between the clamping area and the needle holder, the mixing chamber being provided in the inserted element. 11. A bone marrow removal system, characterized in that it comprises a device according to any of the preceding claims. The removal system according to claim 11, characterized in that the system comprises a mixing chamber connected to the needle of a device as well as at least one input channel and at least one output channel. The removal system according to claim 11 or 12, characterized in that an inlet channel is connected to a source of anticoagulant product. The removal system according to any of claims 11 to 13, characterized in that the outlet channel is connected to a pith collection reservoir. The removal system according to any of claims 11 to 14, characterized in that the system comprises suction means connected to at least one needle. The removal system according to claim 15, characterized in that the suction means comprise a vacuum pump. The removal system according to claim 15 or 16, characterized in that the suction means are controlled by means of a controller, like a pedal operated by the user. The removal system according to any of claims 11 to 17, characterized in that the inlet channel projects into the mixing chamber in the direction of the outlet channel to create a venturi effect. The removal system according to any of claims 11 to 18, characterized in that the system comprises a timer device for regulating the duration of the bone marrow aspiration phases. A bone marrow injection system, characterized in that it comprises a device according to any of claims 1 to 10. 21. The injection system according to claim 20, characterized in that the device is connected to a pith reservoir. Bone, the reservoir being connected to distribution means. 22. The injection system according to claim 20 or 21, characterized in that the distribution means comprise a pump, such as an electric push-syringe pump or a C02 pump. 23. The removal and / or injection system according to any of claims 11 to 22, characterized in that the system is packaged in sterile form.